Medical device manufacturer Boston Scientific is facing renewed scrutiny from the federal prosecutors and the Security Exchange Commission (SEC) for an implantable heart defibrillator recall it issued earlier this month after failing to get FDA approval for manufacturing changes.
According to internal documents obtained by the Wall Street Journal, the Department of Justice (DOJ) has issued subpoenas and the SEC has started an informal inquiry into the medical device manufacturer’s actions, following a recall issued for all of their implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15.
The company said it issued the recall after it realized that it had made two manufacturing changes that were not approved by FDA, which is a regulatory requirement. Boston Scientific described the incident as a clerical oversight and said that there had been no safety issues related to the changes. The FDA, which is also investigating the recall, must approve the changes before the devices can be put back on the market.
Both the DOJ and SEC are asking the company to turn over documents concerning its discovery that they had not received FDA approval for the changes. They are also looking for records of Boston Scientific’s communications with stockholders, doctors and regulators about the recall.
The new probes comes as Boston Scientific is already dealing with DOJ criminal charges against Guidant LLC, a Boston Scientific subsidiary, for allegedly hiding information regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs that, in some cases, resulted in death. Boston Scientific announced last November that it intends to pay $296 million in connection with the charges against Guidant. The DOJ says it expects that Boston Scientific is likely to enter a guilty plea in connection with the charges.
The criminal charges are related to earlier defibrillator manufacturing changes that prosecutors say were done to cover up deaths from defective defibrillator designs. The DOJ charges say that Guidant failed to inform the FDA of the changes in order to avoid scrutiny. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.
The Prizm series, which was included in the criminal investigation, is also one of the units affected by the latest recall for unapproved manufacturing changes. Other defibrillator lines affected by the recall include the Cognis, Confient, Livian, Renewal, Teligen and Vitality ICDs and CRT-Ds.